- Policy
- GOV to bring 1.5 mil COVID-19 vaccines from Romania
- by Kim, Jung-Ju Sep 3, 2021 06:03am
- The Korean government has secured 1,503,000 doses of Pfizer and Modena’s COVID-19 vaccines from Romania and will bring the vaccines to Korea in two shipments this week and next week. The swap was made in line with cooperation for preventive measures against the pandemic that was discussed between the two countries from last month to exch
- Policy
- Eligibility for adjustment applications improved
- by Lee, Hye-Kyung Sep 2, 2021 05:59am
- The criteria for adjustment applications that affect drugs subject to pricing calculations will be improved. On the 2nd, the Health Insurance Review and Assessment Service (HIRA) will present the ‘proposal to improve the assessment criteria for drugs that apply for drug pricing adjustments’ as an agenda for deliberation for its Drug Rei
- Policy
- The MOHW objected to improved benefit for Prolia
- by Lee, Jeong-Hwan Sep 1, 2021 05:57am
- The MOHW objected to the criticism that it should continue to apply health insurance benefits of advanced bio-new drug Prolia (Denosumab), which treats osteoporosis, regardless of bone density figures. The MOHW said patients who still have low bone density measurements in follow-up tests after administering osteoporosis treatments such as Pro
- Policy
- Lucentis biosimilars have been applied to the MFDS
- by Lee, Tak-Sun Sep 1, 2021 05:57am
- Along with Chong Kun Dang, Samsung Bioepis also applied for permission to the MFDS for Lucentis biosimilar. Lucentis (Ranibizumab) is a treatment for ophthalmic diseases that treat macular degeneration and various eye damage, and it is a blockbuster with annual global sales reaching ￦4.6 trillion and sales of ￦37 billion in Korea as of l
- Policy
- DREC to include patient and civic groups' recommendations
- by Lee, Hye-Kyung Sep 1, 2021 05:57am
- In addition to experts recommended by consumer groups, experts recommended by patients and civic groups will also be included in the 8th Drug Reimbursement Evaluation Committee (DREC) that will be commissioned next month. Also, detailed guidelines that did not exist before for DREC’s subcommittees were newly established to aid the organi
- Policy
- MFDS requests supplements for porcine islet transplant trial
- by Lee, Tak-Sun Aug 31, 2021 06:14am
- Experts from the Ministry of Food and Drug Safety expressed the opinion that supplementary data is necessary for the clinical trial protocol studying a xenotransplantation product that transplants islet cells isolated from pigs to diabetic patients. With such an opinion issued, it seems that some time would be required before the clinical
- Policy
- There is a need to apply the HPV vaccine NIP Men Under 17
- by Lee, Jeong-Hwan Aug 31, 2021 06:13am
- President Moon promises free vaccination for girls under 12 → girls under 17. In addition, there is a need for free vaccination of male teenagers of the same age group. HPV, which causes cervical cancer, claims that the country needs to expand vaccination because it can infect both men and women through sexual contact and causes various di
- Policy
- Korean pharmas are pursuing various SGLT-2 combos
- by Lee, Tak-Sun Aug 30, 2021 05:55am
- Companies are busy developing combination therapies combining the latest diabetes treatment, SGLT-2 inhibitors, with existing diabetes treatment. In particular, domestic companies that are eyeing the SGLT-2 market have been testing various combinations for commercialization. On the 26th, the Ministry of Food and Drug Safety approved the P
- Policy
- The patent for Breast Cancer Therapy Affinitor has been clos
- by Lee, Tak-Sun Aug 30, 2021 05:55am
- The patent suit for Affinitor, which was conducted by Novartis and Kwang Dong, was finally closed due to the plaintiff's withdrawal. As a result, Kwang Dong and Samyang Biopharm are able to market more actively. According to the industry on the 26th, the lawsuit against the use patent of Afinitor, which has been filed since March last year
- Policy
- Regulation of COVID-19 vaccines is imminent
- by Lee, Jeong-Hwan Aug 27, 2021 05:59am
- As the "Special Act on the Development of Public Health Crisis Response Medical Products and the Emergency Supply" sub-enforcement decree passed the Regulation Reform Committee preliminary review, regulations and management such as COVID vaccines will be strengthened. The MFDS plans to conduct a follow-up investigation of the public health
